Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

Allergan

Status and phase: Withdrawn; Phase 3

Conditions: Migraine Disorders

Treatments: Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03193359

1313-302-008

Details and patient eligibility

About

This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Has successfully completed the double-blind study (1313-301-008).

Exclusion criteria

• Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
• Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
• Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

BOTOX®

Experimental group

Description:

BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections to head/neck areas at Day 0 and Week 12.

Treatment:

Biological: botulinum toxin Type A